NCT02942082

Brief Summary

Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2018

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

October 19, 2016

Last Update Submit

September 16, 2019

Conditions

Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

  • Post-bleaching hypersensitivity assessed using visual analogue scale

    using visual analogue scale

    one month

Secondary Outcomes (1)

  • Tooth color assessed using value-ordered VITA® Classical Shade Guide

    one month

Study Arms (2)

ACP oral care geldesensitizing agent

EXPERIMENTAL

a desensitizing agent will be applied on tooth before and /or after bleaching.

Other: ACP oral care gel

glycrin

PLACEBO COMPARATOR

glycrin will be applied on tooth before and /or after bleaching.

Other: glycrin

Interventions

ACP oral care gelOTHER

a desensitizing agent will be applied on tooth before and/or after bleaching

ACP oral care geldesensitizing agent
glycrinOTHER

glycrin will be applied on tooth surface before and/or after bleaching

glycrin

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must show no signs of spontaneous dental pain.
  • Male or female patients between the ages of 18 to 40.
  • Patients with good general and oral health.
  • Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
  • Patients should have central incisors determined to be shade C2 or darker

You may not qualify if:

  • Patient with spontaneous dental pain.
  • Patient with anterior restorations or non carious cervical lesion.
  • Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
  • Tempro-mandibular joint problems involving symptomatic pain.
  • Patients taking analgesics that could alter their normal pain perception level.
  • Pregnant or breast feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Cairo university

Cairo, 11651, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 21, 2016

Study Start

November 1, 2017

Primary Completion

September 1, 2018

Study Completion

November 29, 2018

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)